Back to resultsEffect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
Primary Purpose
Postoperative Delirium
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lobectomy
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Delirium
Eligibility Criteria
Inclusion Criteria:
- 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ
Exclusion Criteria:
- Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
es-ketamine
saline
Arm Description
es-ketamine 0.5mg/kg iv
iv saline with the same volume of es-ketamine
Outcomes
Primary Outcome Measures
Postoperative Delirium
Confusion Assessment Method (CAM) or CAM-ICU for patients
Postoperative Cognitive Assessment
Montreal Cognitive Assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04969523
Brief Title
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
Official Title
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy
Detailed Description
This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
es-ketamine
Arm Type
Experimental
Arm Description
es-ketamine 0.5mg/kg iv
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
iv saline with the same volume of es-ketamine
Intervention Type
Procedure
Intervention Name(s)
lobectomy
Intervention Description
Intravenous es-ketamine 0.5mg/kg or saline during lobectomy
Primary Outcome Measure Information:
Title
Postoperative Delirium
Description
Confusion Assessment Method (CAM) or CAM-ICU for patients
Time Frame
7 days after operation
Title
Postoperative Cognitive Assessment
Description
Montreal Cognitive Assessment
Time Frame
7 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ
Exclusion Criteria:
Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
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